Fresenius Medical Care recalls Blood Pump Rotor model F40015481 Rev A due to reported loose guide sheaves causing potential dislodgement in clinical use. Affected units may need inspection or replacement.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Fresenius Medical Care is recalling blood pump rotors with model number F40015481 Rev A after clinics reported loose or dislodged guide sheaves. This could lead to mechanical failure during use, potentially affecting patient safety.
The rotor's guide sheaves can become loose or dislodged after use, which may cause mechanical failure during blood pump operation. This could potentially lead to interruption of blood flow or other complications in clinical settings.
Healthcare facilities using the F40015481 Rev A blood pump rotor model are most at risk. Patients receiving treatment with this specific model may be affected if the rotor becomes dislodged.
Check for the model number F40015481 Rev A on the blood pump rotor. This model was sold with all Rev A lots and is used in clinical settings.
Verify the model number on the blood pump rotor to confirm it is F40015481 Rev A.
Reach out to Fresenius Medical Care for guidance on next steps if the rotor is affected.
The recall is for healthcare facilities using the rotor. Patients are affected if the facility uses the recalled model and the rotor becomes dislodged.
Check for the model number F40015481 Rev A on the blood pump rotor. This model was sold with all Rev A lots and is used in clinical settings.
Contact Fresenius Medical Care for guidance on next steps if the rotor is affected.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1866-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1866-2024 from Fresenius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
